Valid methods: the quality assurance of test method development, validation, approval, and transfer for veterinary...

Area of Science:

• Veterinary diagnostics
• Laboratory quality management
• Analytical chemistry

Background:

• Third-party accreditation demonstrates laboratory competence but is insufficient for data credibility.
• Validated test methods are essential for a valid measurement system, as recognized by ISO/IEC 17025.
• ISO/IEC 17025 mandates that adopted or developed methods be appropriate for their intended use and validated.

Purpose of the Study:

• To discuss considerations and recommendations for veterinary diagnostic test method development, validation, evaluation, approval, and transfer.
• To provide guidance within the ISO/IEC 17025 framework for ensuring test method reliability.
• To emphasize the importance of planned activities, qualified personnel, and adequate resources for method development.

Main Methods:

• The article synthesizes recommendations from national and international standards and guidelines.
• It incorporates practical experience in evaluating method development, validation, and quality management systems.
• The focus is on the ISO/IEC 17025 environment for laboratory testing.

Main Results:

• Accreditation alone does not guarantee data credibility; method validation is a critical first step.
• ISO/IEC 17025 requires validation of laboratory-developed and adopted methods for intended use.
• Method development and transfer must be planned, resourced, and executed by qualified personnel.

Conclusions:

• Validated methods are fundamental to establishing data credibility in veterinary diagnostic testing.
• Adherence to ISO/IEC 17025 standards for method development and validation is crucial.
• Implementing robust processes for method validation and transfer ensures reliable results for end-users.